Good Afternoon, I’d like to thank Ambassador Nicholson (Jim Nicholson, Ambassador, American Embassy to the Holy See) for his kind introduction and for his invitation to speak to you this afternoon about U.S. regulatory policies for biotech foods, or as we refer to them in the United States, genetically engineered foods.

It is indeed both an honor and a privilege to be here today and share with you the many ways that the United States government assures the safety of genetically engineered foods so that scientific advances in food production may benefit not only the American people, but people throughout the world.

I would like to commend the forward thinking and support of the Holy See in recognizing and publicly acknowledging the potential for the technology of genetically engineered foods to be part of the framework of the Vatican’s efforts to promote human dignity by eradicating poverty, hunger, and malnutrition and promoting economic well-being. The U.S. especially applauds the support of the Holy See for a science-based approach to this issue.

Already today at this conference you have heard how the scientific advances in genetically engineered crops offer new promise not only for feeding the millions of hungry people around the world, but also for improving the nutrition and health of all people. You have also heard how biotech food crops can aid developing countries in reaching food sufficiency and enhancing their economic development, and how small farmers in Africa and the Philippines are already using genetically engineered food crops to their advantage.

It is my pleasure to share with you today the extensive system of safeguards that the U.S. government has in place to assure the safety of genetically engineered foods not only for the American people, but also for people around the world who import U.S. food crops and manufactured foods, and for those who receive U. S. food crops as food aid through the United Nations World Food Programme.

Background

The United States has more experience in the regulation of genetically engineered foods than any other country in the world. In 1986, under the guidance of the White House Office of Science and Technology Policy, the United States developed a coordinated framework for the regulation of genetically engineered products. The decision was made that genetically engineered products (foods and drugs) would be regulated under existing legal authorities, and that safety assessments would be based on product characteristics. In other words, the U.S. regulates the product and not the process by which the product was developed. The U.S. Government agencies directly involved in these regulatory policies include the Department of Health and Human Services’ Food and Drug Administration (FDA) and National Institutes of Health (NIH), the Department of Agriculture (USDA) and the Environmental Protection Agency (EPA).

The distribution of responsibilities among these agencies is clear. The USDA oversees the safety for the cultivation of genetically engineered crops and addresses plant protection issues. The EPA is responsible for overseeing the safe use of pesticides, including pesticidal substances produced in genetically engineered plants. EPA also sets tolerances or establishes exemption of tolerance for these pesticidal compounds in foods and in the environment. The NIH, as the premier research agency in the U.S. Government establishes the guidelines for recombinant DNA research. The FDA, the agency I represent, has the major responsibility for assuring the safety and proper labeling of foods, feed, and pharmaceutical substances derived from genetically engineered plants. The agency’s statutory authority for these activities are codified in the Federal Food Drug and Cosmetic Act which gives FDA oversight of all cereals, fruits, vegetables, plant by-products, milk, seafood, and all substances added to foods. FDA also is responsible for post-market monitoring of foods for adulteration, for pre-marketing approval of food additives, and for assuring appropriate labeling of food products.

In 1990, the first food additive produced through genetic engineering, a form of chymosin, a milk-clotting enzyme used for cheese production, was affirmed as being virtually identical to its natural counterpart and granted GRAS status (generally recognized as safe).

The first genetically engineered whole food crop was introduced into commercial production in the U.S. in 1994. By 2001, more than 109 million acres worldwide were planted with bioengineered crops and this acreage has continued to grow.

The United States accounts for about two-thirds of all the bioengineered crops planted globally. The social and economic benefits derived from the use of genetically engineered food crops has been widely recognized by U.S. farmers, to the extent that, as of 2002, at least 68 percent of the soybean crop planted in the U.S. consisted of genetically engineered varieties along with approximately 26 percent of the corn crop, over 70 percent of the cotton crop, and about 55 percent of the canola crop.

Most of these genetically engineered crop varieties consist of herbicide or insect resistant varieties. These types of crop varieties could be invaluable to developing countries in helping them toward food sufficiency. Opportunities abound for the development of genetically engineered crop varieties with enhanced nutritional content such as the increased vitamin A content of golden rice that can improve the health and nutritional status of those most in need.

U. S. Government Policy for Genetically Engineered Foods

The FDA established its basic policy on genetically engineered foods in 1992. This is the policy, along with subsequent clarifications that is in effect today. This “ Policy on Foods Derived from New Plant Varieties” [PDF] was published to provide guidance to developers and producers of new plant varieties, and applies to all methods of plant breeding, including techniques using recombinant DNA.

The basic principles in this policy statement are: 1) that the regulation of new plant varieties should be based on the objective characteristics or components of the food, rather than the method used to develop the food; 2) new foods must be as safe as foods already on the market; and, 3) new plant varieties are evaluated relative to traditional counterparts.

New substances introduced into food via plant breeding (either traditional or bioengineered) are considered food additives if they are not GRAS or pesticides.

In 1995, we provided additional guidance on a voluntary consultation process whereby producers of genetically engineered foods voluntarily notify the agency before marketing a bioengineered crop seed or food. This prior notification is to ensure that new food products are safe and lawful. Genetically engineered crops are evaluated on a case-by-case basis, there is no “required’ battery of tests. The level of consultation needed is dependent on the novelty of the genetically engineered product.

Notification leads to a two-part consultative process that involves a discussion of relevant safety, nutritional, and other regulatory issues and a subsequent submission by the developer of a safety assessment report. The safety assessment involves a multi-disciplinary approach that includes the agronomic and quality characteristics of the plant, the characteristics of new substances that are introduced into the plant through genetic engineering, a genetic analysis, and a chemical and nutritional analysis.

Safety Evaluation

All foods, whether conventional or bioengineered, pose the same types of inherent risks to human health: the potential to contain toxins, allergens, and antinutrients. Safety assessments for bioengineered foods thus should focus on whether the genetic change alters the potential toxicity, allergenicity or level of antinutrients compared to the conventional food source. In addition, FDA encourages an evaluation of the safety of intended changes to nutrient composition and compositional analysis for unintended changes.

Specific elements of the safety evaluation include:

Analysis of the intended modification or new substance relative to its identity, source, digestibility, dietary exposure and nutrition characteristics,

Analysis of unintended modifications as to the genetic stability over multiple generations, analysis of nutrient, anti-nutrient and toxicant levels,

Characteristics of the host plant, including its taxonomy, history of safe use, normal presence of harmful constituents and important nutrients,

Characteristics of the donor organism including its taxonomy, history of use, presence of harmful constituents, passage through microbial hosts, and the identity and function of the introduced material,

Analysis of the substance introduced into the host plant including the concentration of the expression product, its potential for allergenicity and for toxicity, its similarity to other substances in the food supply, and whether it causes alterations in plant metabolism, and

Evaluation of the inserted genetic material in terms of the methods of transformation used, the activity of the regulatory sequences of the gene the number of inserts and insertion sites, and its genetic stability.

FDA also developed additional guidance for the food industry regarding safety assessments for the use of antibiotic resistance marker genes in bioengineered plants. This guidance indicated that when such genes are used, the safety assessment should also determine whether the presence in food of the enzyme or protein encoded by the antibiotic resistance marker gene would compromise the therapeutic efficiency of orally administered antibiotics through transfer of the gene from plants to microorganisms in the gut of man or animal, or in the environment.

More recently we issued draft guidance for industry on voluntary labeling to indicate whether foods have or have not been developed using bioengineering. This document lays out four guiding principles on appropriate ways the industry could voluntarily provide information on a food label about bioengineering.

To date, bioengineered foods have proven to be no different from their conventional counterparts and so, although FDA issued a proposed rule in 2001 concerning making the voluntary notification of intent to market mandatory, this rule has not yet been finalized and the voluntary notification procedures remain in effect.

I’m pleased to report that to date all developers of bioengineered foods have voluntarily consulted with FDA prior to marketing their products, and FDA maintains a listing of these completed consultations on our website. I am also pleased to tell you that the procedures that the U.S. Government has had in place for assuring the safety of genetically engineered foods since 1992 are fully compatible with the Principles and Guidelines on Foods Derived from Biotechnology adopted by the Codex Alimentarius in July of 2003.

While it is true that FDA evaluates genetically engineered foods for the U.S. population, the U.S. has a very ethnically and racially diverse population that also includes large numbers of sick and elderly. Thus, assurance of safety for the extremely diverse U.S. population should reflect its safety for non-U.S. populations. FDA would not allow a food to be marketed if it believed that the food would cause harm for some segment of the population, unless the food could be clearly labeled to alert specific sub-populations (e.g. those with allergic reactions).

The characteristics of genetically engineered varieties of food crops, available to date, have focused primarily on insertion of genes that confer herbicide or pest resistance or both to the plant, or alter ripening characteristics or oilseed composition. There is no scientific evidence to indicate that there would be a greater risk to consumers or the environment if these crops were grown in developing countries rather than in the United States.

Ongoing Initiatives

To ensure that U.S. policies and procedures on genetically engineered foods stay current with the latest scientific and technological advances, the FDA has a group of outside experts who serve on the Food Biotechnology Subcommittee of the Food Advisory Committee, and provide advice on science-based approaches to assessing potential risks.

In addition, FDA in conjunction with USDA and EPA commissioned the U.S. National Academy of Sciences and the Institute of Medicine to develop a science-based framework to assess or predict unintended health effects of genetically engineered foods to assist us in our evaluation of these products prior to commercialization. This report was released at the end of July of this year and outlined a decision tree for the safety assessment of genetically engineered foods that tracks closely with FDA’s current procedures. The report also confirms FDA’s belief that the genetically engineered foods evaluated by the agency and marketed to date, do not pose unexpected health concerns for consumers.

We are currently nearing completion of a draft guidance concerning field trials of bioengineered food crops. The development of this guidance is a high priority for the Administration and the industry, to enhance public confidence, avoid product recalls, and provide an international model to address the presence of low levels of bioengineered plant material in non-bioengineered crop fields.

The goal of this guidance is to ensure that material from field trials is safe prior to any inadvertent entry into the food supply. In essence, this would be the protein safety component of a full voluntary consultation relative to the protein’s toxicity or allergenicity. It would not replace the full consult prior to marketing.

Pharmaceutical Crops

With continued and rapid advances in biotechnology come many new and interesting challenges for FDA. The production of food crops engineered to produce pharmaceutical and industrial compounds is one of these challenges. While FDA has sole responsibility for ensuring the safety and efficacy of the pharmaceutical products produced by plants for use in humans, we share the responsibility for ensuring the safety of these products developed for use in animals with USDA. Currently, FDA is considering an adventitious presence guidance document analogous to that for food-use crops.

However, if a genetically engineered plant whose new characteristics have not been affirmed as GRAS or received previous approval as a food additive should inadvertently get in to the food supply, the FDA has procedures in place under existing legal authorities to remove the contaminated foods from the market.

This was well demonstrated in the U.S. Government response in 2000 to the appearance of StarLink corn in the food supply, StarLink contains a pesticidal protein that makes corn resistant to certain types of insects, and had not been approved for human consumption. At FDA’s urging, corn dry-milling operations began a testing program to screen all yellow corn intended for human food use. This testing program remains in effect today, even though the frequency with which the StarLink gene is being detected has declined significantly. Should the U.S. government develop a revised testing protocol leading to an exit strategy for domestic testing as the presence of contaminated product declines, this will not preclude continued testing of food-aid corn

U.S. Government Assistance in Capacity Building

Because of our extensive experience in evaluating the safety of genetically engineered foods, FDA and other relevant agencies of the U.S. Government participate extensively in capacity building programs to assist other nations in developing appropriate regulatory frameworks. For example, FDA has conducted joint training sessions with our colleagues in Canada, Australia, and other countries for representatives of other governments to teach them about food safety assessments of genetically engineered foods. Workshops have been conducted in Moscow for the Russian Federation and neighboring countries, in Mexico, and just in the past few weeks we conducted a workshop in Jakarta for ten Southeast Asian countries.

In addition, FDA provides scientific technical assistance in conjunction with the U.S. Agency for International Development (USAID), the Dept. of State and the USDA Foreign Agriculture Service in meetings with health officials from other countries. In October of this year, the U.S. Government is sponsoring a meeting in New Delhi on U.S. – India regulatory issues.

FDA also routinely meets and shares U.S. Biotechnology regulatory processes with foreign regulatory officials who come to the U.S.

Conclusion

In closing, let me just say that FDA, as the federal agency charged with safeguarding the public health of the U.S. population, is grateful to the Pontifical Academy of Sciences and the Vatican for the foresight in recognizing and advocating for the tremendous potential of genetically engineered food crops to enhance the ability to feed the hungry of the world, to contribute to improved nutrition and health of the world population, and to enhance food production capabilities in developing countries.

Your efforts to convey the facts about genetically engineered foods to needy countries constitute a real service to humanity. We must continue to work with the UN World Food Programme and other International agencies to help equalize the chances for the people of all nations to have safe and adequate supplies of food in order to live healthy and productive lives.